Health Management Model Construction and Effect Evaluation of Hypertension Patients Based on Disease-related Health Literacy

March 27, 2020 updated by: ZHANG Qing-hua, Huzhou Normal University
Huzhou City, Zhejiang Province was chosen as the research site, and a general hospital was randomly selected. The "Chinese version of hypertension health literacy scale" of the tutor of this research group was used to evaluate the health literacy level of inpatients with hypertension in the Department of Cardiology, and the patients with critical and lack of health literacy were selected as the research objects. In the control group, routine health management was carried out. On the basis of the control group, the intervention group used health education tools combined with health literacy intervention to implement interactive health management for 12 months. The results of the intervention measures were compared to evaluate the effects of the intervention measures on improving the health literacy level, Hypertension Self-care ability, quality of life and reducing systolic and diastolic blood pressure, body mass index, waist circumference, physiological and biochemical indicators of the patients, so as to provide theoretical basis and practical reference for the further development of prevention and treatment strategies of hypertension patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

First, the Chinese version of hypertension health literacy scale was used to evaluate the health literacy of inpatients in a hospital, and then the critical and lack of health literacy patients were selected as the research objects.

Then, taking a place in Huzhou City of Zhejiang Province as the research site, a general hospital was randomly selected. According to the ratio of male to female = 1:1, the hypertension patients who meet the inclusion criteria were screened until the intervention group and the control group reached the required sample size. Patients were randomly assigned to the intervention group and the control group.

After the patients signed the informed consent, the patients were intervened. Finally, data collection and statistical processing are carried out

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria：

  • Age ≥ 16 years old and has lived in Huzhou for nearly half a year;
  • The Chinese version of the hypertension health literacy scale was used to evaluate the health literacy of those with a total score of less than 32 + the critical group;
  • In line with the diagnostic criteria for essential hypertension set out in China's hypertension prevention and control guidelines in 2018, systolic blood pressure ≥ 140mmHg, and / or diastolic blood pressure ≥ 90mmHg;
  • In the last half year, the living condition is stable, and there is no major stress event (such as the death of relatives, etc.);
  • Volunteer to participate in the study, and sign the informed consent of research willingness.

Inclusion Criteria：

  • All kinds of secondary hypertension patients;
  • Major stress events occurred during the study period;
  • Have serious mental disorder or serious cognitive function defect;
  • Patients with severe acute and chronic physical diseases；
  • Cardiovascular risk factors: low risk or high risk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental : intervention group
Combination of health education tools and health literacy intervention: on the basis of the control group, the hypertension health education tools are used as the education media to encourage patients to find out the elements of the tool chart, use the picture content to guide the topic development, encourage patients to discuss with each other, realize heuristic questions, rather than a single indoctrination, so as to deepen the understanding and memory of patients. At the end of the course, patients are encouraged to set short-term goals to encourage behaviors that continue to achieve larger goals. At the same time, health literacy lectures were organized during the hospitalization. Health literacy lecture is mainly to learn the information that hypertension needs to pay attention to in order to improve the health literacy of hypertension patients and other indicators.
Behavioral: Health education tools combined with health literacy intervention
On the basis of the control group, the intervention measures to improve the health literacy of patients were implemented and self-made health education tools were used. During hospitalization, health knowledge lectures shall be organized for patients. Before the activity, the theme of the activity shall be clarified. Each participant shall be organized by the educator to sit on the tool chart in a U-shape. According to the theme of the tool map, patients interact with educators. And learn the knowledge content related to hypertension health literacy. Before the end of the activity, the educator will review all the contents discussed in the activity quickly, answer the questions in the activity, and help the participants to sort out and consolidate the knowledge acquired in the education. Follow up intervention for patients after leave hospital.
NO_INTERVENTION: No intervention:The control group
No intervention except conventional care were performed for the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High Blood Pressure-Health Literacy Scale into Chinese
Time Frame: 12 months
The scale consists of 15 items and 5 dimensions, with a total score of 0-60. One score will be given if one question is answered correctly. The higher the score is, the higher the HL level is. According to the TOFHLA classification standard, HL level is divided into three levels. If the score is less than 32, the HL level is deficient; if the score is 32-40, the HL level is critical; if the score is more than 40, the HL level is sufficient. The score of the scale before and after the intervention was compared.
12 months
Systolic and diastolic blood pressure in hypertension
Time Frame: 12 months
The decrease of systolic and diastolic blood pressure in hypertension patients after health literacy intervention
12 months
Body Mass Index ，BMI
Time Frame: 12 months
According to 2008 WHO guidelines, BMI < 25 kg / m2 is normal weight or low weight, 30 kg / m2 > BMI ≥ 25 kg / m2 is overweight, BMI ≥ 30 kg / m2 is obesity. To evaluate the changes of BMI of patients before and after intervention
12 months
Waist Circumference，WC
Time Frame: 12 months
WC ≥ 102CM in male and 88cm in female were abdominal obesity, 94cm ≤ male WC < 102CM, 80cm ≤ female WC < 88cm are abdominal overweight, WC < 94cm in male and 80cm in female is normal.To evaluate the changes of WC of patients before and after intervention
12 months
Quality of Life Instruments for Chronic Diseases - Hypertension V2.0: scale scores
Time Frame: 12 months
The scale consists of 41 items and uses the five point equidistant scoring method. The scores are 1, 2, 3, 4 and 5 in turn. The total score of the scale is between 41 and 205. The higher the score, the better the quality of life.Compare the changes of the scale scores before and after the intervention
12 months
Chinese version of Hypertension Self-care Profile
Time Frame: 12 months
There are 60 items in the scale. Each item in the scale is 1-4 points, and the total score of the scale is 60-240 points. The higher the score, the better the self-care ability. Compare the changes of patients' scale scores before and after intervention
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting Glucose, Glu
Time Frame: 12months
Comparison of changes in indicators before and after intervention
12months
Low Density Lipoprotein, LDL
Time Frame: 12 months
Comparison of changes in indicators before and after intervention
12 months
The self rated health status of the patients
Time Frame: 12 months

Draw a scale with a minimum of 0 and a maximum of 100. 0 represents the worst health condition in the patient's mind, and 100 represents the best health condition in the patient's mind.

Please mark the health status of the participants on the scale to help them reflect the health status
12 months
Total Cholesterol, TC
Time Frame: 12 months
Comparison of changes in indicators before and after intervention
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huzhou Normal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2020

Primary Completion (ANTICIPATED)

May 1, 2021

Study Completion (ANTICIPATED)

August 1, 2021

Study Registration Dates

First Submitted

February 29, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (ACTUAL)

March 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HuzhouNormalU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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